Xper Information Management System 98960612834x

GUDID 00884838098985

The information management system is intended for use under the direct supervision of a healthcare practitioner for acquiring, displaying, trending, storing and transmitting various types of data, such as physiologic, hemodynamic, clinical, medical image and other related data. The system is capable of processing / analyzing information, such as multi-channel ECG signals, and performing other data management functions, such as creating reports. Data may be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. The system is indicated for use in the following areas: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and surrounding areas where access to the information is needed. The system consists of modules and may be entirely a software offering or a hardware/software offering. It is intended for use on standard computer systems and does not require proprietary hardware. The solution is available as a single module or combination of modules, or may function as a standalone system. The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or internet, or may function as a standalone device.

Philips Medical Systems Nederland B.V.

Patient health record information system
Primary Device ID00884838098985
NIH Device Record Keye2ca3a6f-1b0a-4bc1-8eb6-fa78441fda69
Commercial Distribution StatusIn Commercial Distribution
Brand NameXper Information Management System
Version Model Number2.6
Catalog Number98960612834x
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(999)999-9999
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Device Identifiers

Device Issuing AgencyDevice ID
GS100884838098985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-15
Device Publish Date2020-01-07

On-Brand Devices [Xper Information Management System]

00884838087330The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838085213The information management system is intended for use under the direct supervision of a healthca
008848380812912.2
008848380707212.1
008848380706911.5
00884838091771The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838098985The information management system is intended for use under the direct supervision of a healthca
00884838100084The Xper Information Management System is used for acquiring, displaying, trending, storing and
00884838105034The Information Management System is a software to acquire, display, trend, store, and transmit

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